Comparison of the Effects of Robotic Rehabilitation, Functional Electrical Stimulation and Occupational Therapy on Upper Extremity and Hand Functions in Tetraplegic Patients With Spinal Cord Injury
Key facts
- Who runs it
- Ankara City Hospital Bilkent
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 30 people enrolled
- Started
- 1 Apr 2025
- Ended
- 30 Sept 2025
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- robotic rehabilitation
- Functional Electrical Stimulation
- occupational therapy
- Record updated
- 12 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Age ≥18 years
- Incomplete tetraplegia
- No cognitive impairment (Mini-Mental State Exam score ≥25)
- No significant visual deficits
- Ability to sit upright for at least 30 minutes
- No prior exposure to these treatments in the last six months
Who cannot take part
- Pre-existing neurological, rheumatological, or orthopedic conditions affecting upper extremity
- Severe cardiovascular disease
- Open wounds or infections at application sites
- Active deep vein thrombosis or thrombophlebitis in the upper extremity
- History of epilepsy or cyber disease
- Severe upper extremity spasticity (MAS score 3-4)
- Severe shoulder pain or joint ROM restriction (>50%)
- Uncontrolled aggressive behavior
- Aphasia affecting comprehension
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
2. Purpose and Significance of the Study (Primary and Secondary Objectives, if any) Spinal cord injury (SCI) is a clinical condition characterized by partial or total loss of motor, sensory, and autonomic functions below the level of the lesion, depending on the severity and level of the injury, which may be caused by traumatic or non-traumatic factors.
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Globally, the incidence of SCI is estimated to be 250,000-500,000 cases per year . SCI patients may be classified as tetraplegic or paraplegic according to their functional levels. In paraplegia, there is a loss of function in both lower extremities, whereas tetraplegic patients experience functional loss in all four extremities. In both groups, autonomic dysfunctions in visceral organs can also be observed depending on the severity of the injury below the lesion level.
In tetraplegic patients, loss of upper extremity and hand functions significantly reduces their level of independence in daily living activities, particularly in self-care tasks, and considerably lowers their quality of life. Therefore, upper extremity and hand rehabilitation play a crucial role in the comprehensive rehabilitation program for tetraplegic patients. Various rehabilitative modalities have been used both in clinical practice and in the literature to improve upper extremity and hand functions. The use of advanced rehabilitation technologies has increased in recent years. Studies on functional electrical stimulation (FES) for upper extremity, robotic rehabilitation, virtual reality applications, mirror therapy, and similar approaches have become more prevalent in the literature . However, there is a limited number of studies comparing the superiority of these rehabilitation techniques in tetraplegic patients, leading to insufficient data for selecting the most appropriate rehabilitative technologies in clinical practice.
This study aims to compare the effects of FES, robotic rehabilitation, and occupational therapy on upper extremity and hand functions in tetraplegic patients. Additionally, it seeks to determine which patient groups, based on their clinical and demographic characteristics, would benefit the most from each therapy and to contribute to the development of personalized rehabilitation strategies by analyzing outcomes in the acute, subacute, and chronic phases of SCI.
The 3 groups in the trial
- robotic rehabilitationExisting treatment, for comparison
It is planned to provide a robotic rehabilitation program for patients in the robotic group, in addition to conventional rehabilitation for 4 weeks, with 30 minutes, 3 days a week, focusing only on their dominant upper extremities. The program will be individualized for each patient through a treatment prescription consisting of games, tailored to their joint range of motion, muscle strength, functional status, skills, and perception. The goal is for patients to perform task-specific activities on a virtual screen using an exoskeleton (Armeo Power With Manova) robotic system. The robotic systems provide three-dimensional movement ability to the extremity with motor function loss.
Treatment: Functional Electrical Stimulation and occupational therapy
- Occupational therapyExisting treatment, for comparison
In the occupational therapy group, patients will receive the planned treatment in addition to conventional rehabilitation for 4 weeks, three days a week, for 30 minutes. Within the framework of this program, activities of daily living, especially self-care activities (eating, drinking, dressing, combing hair, brushing teeth, turning door handles, using remote controls, phones, and computers), as well as task-specific sensory and motor retraining and fine motor skills, will be worked on.
Treatment: robotic rehabilitation and Functional Electrical Stimulation
- Functional Electrical StimulationExisting treatment, for comparison
In the FES group, an FES bicycle program (RT300 FES leg cycle) will be applied for 4 weeks, three days a week for 30 minutes, focusing on the dominant upper extremity and hand. Electrodes will be placed on the target muscle groups. Electrodes will be placed on the elbow flexors and extensors, wrist flexors and extensors, and finger flexors and extensors. The current intensity will be adjusted according to the patient's tolerance.
Treatment: robotic rehabilitation and occupational therapy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 12 June 2026